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FDA 510(k)

Penumbra System ACE 68 Reperfusion Catheter

K-Number: K161640 · 2016-07-12

ApplicantPenumbra, Inc.
Decision Date2016-07-12
Product CodeNRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Penumbra System ACE 68 Reperfusion Catheter is a medical device manufactured by Penumbra, Inc.. It received FDA 510(k) clearance on 2016-07-12 under approval number K161640. The device is classified under product code NRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Penumbra System ACE 68 Reperfusion Catheter?

Penumbra System ACE 68 Reperfusion Catheter is a medical device that received FDA 510(k) clearance on 2016-07-12. It is manufactured by Penumbra, Inc.. The 510(k) number is K161640.

When was Penumbra System ACE 68 Reperfusion Catheter approved by the FDA?

Penumbra System ACE 68 Reperfusion Catheter received FDA 510(k) clearance on 2016-07-12, under approval number K161640.

What company makes Penumbra System ACE 68 Reperfusion Catheter?

Penumbra System ACE 68 Reperfusion Catheter is manufactured by Penumbra, Inc..

What is the FDA product code for Penumbra System ACE 68 Reperfusion Catheter?

The FDA product code for Penumbra System ACE 68 Reperfusion Catheter is NRY.

Related Clinical Trials

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Other Devices by Penumbra, Inc.

K161506Penumbra Aspiration System K161523INDIGO Aspiration System K161064Penumbra System ACE 68 Reperfusion Catheter K160449Penumbra System, Penumbra Pump MAX K160533Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System) K160832Penumbra Smart Coil

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Related Devices (Code: NRY)

K161879Solitaire Platinum Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular K161064Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc. K160449Penumbra System, Penumbra Pump MAXPenumbra, Inc. K152541Penumbra System ACE 64 and ACE 68 Reperfusion CathetersPenumbra, Inc. K172448Riptide Aspiration SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular K162901Penumbra 3D Revascularization DevicePenumbra, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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